Assessment of wound healing efficacy and local tolerability of a wound gel with intraindividual comparison using an abrasive wound model in a single-center, randomized, investigator-blind clinical investigation - EA-19-02-083

Engelhard Arzneimittel GmbH & Co. KG0 sites33 target enrollmentFebruary 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2020

End Date

March 27, 2020

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Healthy skin on the volar forearms;
•2\. Female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices (IUDs), sexual abstinence or vasectomized partner;
•3\. Urine pregnancy test negative for all females;
•4\. Written informed consent obtained.

•1\. Acne, suntan, eczema, scars, excessive hair, acute skin infection or skin disease, hyper\- or hypopigmentation or tattoos in the test fields;
•2\. Dark\-skinned persons (Fitzpatrick skin types IV–VI);
•3\. Symptoms of a clinically significant illness that may influence the outcome of the investigation in the 4 weeks before baseline and during the clinical investigation;
•4\. Participation in the treatment phase in another clinical investigation or clinical trial within the last 4 weeks prior to the baseline visit of this clinical investigation and during the conduct of this investigation;
•5\. Known hypersensitivity or known allergic reactions to components of the MD or the protective standard wound plaster used;
•6\. Subjects with diabetes mellitus or presence or history of psoriasis, atopic dermatitis, lichen ruber planus, impaired wound healing or keloid development;
•7\. Contraindications according to the package leaflet/instructions of use (Hansaplast Sensitive);